Hypoparathyroidism and Pseudohypoparathyroidism

Management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. be

Nutritional Rickets or Osteomalacia

Has been used to control serum calcium concentrations and treat vitamin D-dependent rickets† or osteomalacia† in a few adult and pediatric patients.a

Tetany in Premature Infants

Has been used in the prevention of tetany in vitamin D-deficient premature infants with hypocalcemia†; also has been used in the treatment of hypocalcemic tetany in premature infants†. af

Familial Hypophosphatemia

Has been used in conjunction with phosphate supplements in the treatment of bone disorders in adult patients with familial hypophosphatemia† (vitamin D-resistant rickets).af

Calcitriol Dosage and Administration

General

Measure serum calcium concentrations at least twice a week during initial therapy and after subsequent dosage adjustments.abcde Some clinicians recommend measuring serum calcium concentrations at least weekly for the first 12 weeks of therapy and monthly after stabilization of dosage.a

For calcitriol therapy to be effective, patients must have an adequate, but not excessive, daily intake of calcium.bcde

Administration

Calcitriol is administered orallyabe or by IVcd injection, usually in a single daily dose.a

IV Administration

Administer IV by rapid injection through catheter at the end of a period of hemodialysis.a

Hypoparathyroidism and Pseudohypoparathyoidism

Oral

Children ≥1 years old: Initially, 0.25 mcg daily. a Since only a limited number of children <6 years of age with pseudohypoparathyroidism have received the drug, dosage recommendations for such children currently do not exist.abe

If adequate clinical and biochemical responses are not obtained with initial dosage, increase dosage at 2- to 4-week intervals.a

Oral

Oral

Special Populations

Geriatric Patients

Select dosage with caution (generally starting at the low end of the dosing range) because of age-related decreases in hepatic, renal, and/or cardiac function, and concomitant disease and drug therapy.be

Warnings/Precautions

Warnings

Hypercalcemia

Chronic hypercalcemia increases risk of soft-tissue calcification, including vascular calcification and nephrocalcinosis.be Radiographic evaluation of suspected areas may be useful in early detection of calcification.bcde

Vitamin D and its analogs should not be used during calcitriol therapy, because of possible additive effects.bcde

Hyperphosphatemia and Hypercalciuria

Risk of hyperphosphatemia.b Use a non-aluminum-containing phosphate binder and a low-phosphate diet to control serum phosphorus concentrations in patients undergoing dialysis.bcde Risk of hypercalciuria.bcde

Hypermagnesemia

Magnesium-containing antacids should not be used concomitantly with calcitriol.be

Importance of immediate reporting of potential manifestations of hypercalcemia.be

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.be

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.be

Importance of informing patients of other precautionary information.be (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Calcitriol

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

0.25 mcg*

Rocaltrol (with parabens)

Roche

0.5 mcg*

Rocaltrol (with parabens)

Roche

Solution

1 mcg/mL*

Calcitriol Oral Solution

Roxane

Rocaltrol

Roche

Parenteral

Injection, for IV use only

1 mcg/mL*

Calcitriol Injection

American Regent

Calcijex

Abbott

2 mcg/mL*

Calcitriol Injection

American Regent

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.